Gestational Diabetes Mellitus (GDM)NCT06884696
Study of Placental Inflammation in Gestational Diabetes
A study testing Blood samples for inflammatory markers and Placental Extract in people with Gestational Diabetes Mellitus (GDM), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Blood samples for inflammatory markers and Placental Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with gestational diabetes mellitus
- Women with uncomplicated pregnancy
- Age >18 years
- Singleton pregnancy
Who cannot join
- Age < 18 years
- Infections (HIV,HCV)
- Multiple pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Placental Inflammation in Gestational Diabetes: the Role of the Inflammosome NLRP3 and the Scavenger Receptor of Inflammatory Chemokines D6
The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6
Read the detailed description
The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Blood samples for inflammatory markers, Placental Extract
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for inflammatory markersOther
Blood sampling
Placental ExtractOther
Placental sampling after caesarean section
| Study group | Role | What they receive |
|---|---|---|
| Women with gestational diabetes mellitus | Experimental | Blood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus Receives: Other: Blood samples for inflammatory markers; Other: Placental Extract |
| Healthy women with uncomplicated pregnancy | Experimental | Blood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy Receives: Other: Blood samples for inflammatory markers; Other: Placental Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental inflammation
Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Tersigni, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884696
- Sponsor's protocol ID
- 4978
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Placental Inflammation in Gestational Diabetes: the Role of the Inflammosome NLRP3 and the Scavenger Receptor of Inflammatory Chemokines D6
- ClinicalTrials.gov ID
- NCT06884696
- Acronym / sponsor ID
- 4978
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6
Detailed description
The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with gestational diabetes mellitus | Experimental | Other: Blood samples for inflammatory markers, Other: Placental ExtractBlood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus |
| Healthy women with uncomplicated pregnancy | Experimental | Other: Blood samples for inflammatory markers, Other: Placental ExtractBlood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with gestational diabetes mellitus
- Women with uncomplicated pregnancy
- Age >18 years
- Singleton pregnancy
Key exclusion criteria (4 listed)
- Age < 18 years
- Infections (HIV,HCV)
- Multiple pregnancy
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for inflammatory markersBlood sampling | Other | Healthy women with uncomplicated pregnancy, Women with gestational diabetes mellitus |
| Placental ExtractPlacental sampling after caesarean section | Other | Healthy women with uncomplicated pregnancy, Women with gestational diabetes mellitus |
Primary outcome
Placental inflammation
Time frame: At delivery/birth
Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Tersigni principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples for inflammatory markers and Placental Extract in people with Gestational Diabetes Mellitus (GDM), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental inflammation (time frame: At delivery/birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.